telmisartan and hydrochlorothiazide

Generic: telmisartan and hydrochlorothiazide

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name telmisartan and hydrochlorothiazide
Generic Name telmisartan and hydrochlorothiazide
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, telmisartan 40 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-462
Product ID 42291-462_485d63fa-bf2a-c390-e063-6294a90a03c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202544
Listing Expiration 2027-12-31
Marketing Start 2024-06-18

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291462
Hyphenated Format 42291-462

Supplemental Identifiers

RxCUI
283316 283317 477130
UNII
0J48LPH2TH U5SYW473RQ
NUI
N0000175359 N0000175419 M0471776 N0000000070 N0000175561

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name telmisartan and hydrochlorothiazide (source: ndc)
Generic Name telmisartan and hydrochlorothiazide (source: ndc)
Application Number ANDA202544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (42291-462-30) / 10 TABLET in 1 BLISTER PACK (42291-462-11)
source: ndc

Packages (1)

42291-462-30 3 BLISTER PACK in 1 BOX (42291-462-30) / 10 TABLET in 1 BLISTER PACK (42291-462-11)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) telmisartan (40 mg/1)

Linked Drug Pages (1)

Telmisartan and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "485d63fa-bf2a-c390-e063-6294a90a03c0", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "U5SYW473RQ"], "rxcui": ["283316", "283317", "477130"], "spl_set_id": ["1b303136-dccd-178b-e063-6394a90a35f8"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 BOX (42291-462-30)  / 10 TABLET in 1 BLISTER PACK (42291-462-11)", "package_ndc": "42291-462-30", "marketing_start_date": "20240618"}], "brand_name": "Telmisartan and Hydrochlorothiazide", "product_id": "42291-462_485d63fa-bf2a-c390-e063-6294a90a03c0", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "42291-462", "generic_name": "Telmisartan and Hydrochlorothiazide", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Telmisartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "TELMISARTAN", "strength": "40 mg/1"}], "application_number": "ANDA202544", "marketing_category": "ANDA", "marketing_start_date": "20240618", "listing_expiration_date": "20271231"}